HIV Infections Clinical Trial
Official title:
Pharmacokinetic Study of the Interaction of Azidothymidine and Methadone in Patients With AIDS and ARC
To determine if methadone treatment will affect the blood levels of zidovudine (AZT) in
patients with AIDS or AIDS-related complex (ARC) who are receiving oral AZT and methadone
therapy. In addition, the blood levels of methadone both before and during AZT treatment
will be studied, and patients receiving daily oral methadone treatment will be evaluated for
signs of narcotic withdrawal during treatment with AZT.
The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide
approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very
likely that an increasingly larger number of AIDS patients receiving AZT therapy will have
had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily
methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large
number of patients who will undergo long-term treatment with both methadone and AZT.
Therefore, the study of potential drug interactions is essential.
The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide
approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very
likely that an increasingly larger number of AIDS patients receiving AZT therapy will have
had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily
methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large
number of patients who will undergo long-term treatment with both methadone and AZT.
Therefore, the study of potential drug interactions is essential.
The 18 patients are patients with AIDS or ARC. Nine are control patients who are not
receiving methadone and are not IV drug abusers. Nine are former IV drug abusers who have
been maintained on methadone for at least 6 months and who have been receiving a constant
daily dose of methadone for at least 1 month. Plasma and urine levels of methadone are
determined over a 4 hour period. The dose of AZT: For the pharmacokinetic study of AZT,
plasma and urine samples are taken after oral dose of AZT and an intravenous dose of AZT in
the control and methadone groups.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment
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